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K Number
K243408
Device Name
TACTIX Vector Syndesmosis System
Manufacturer
Vilex LLC
Date Cleared
2024-11-27

(26 days)

Product Code
HTN,
Regulation Number
N/A
Type
Special
Panel
OR
Reference & Predicate Devices
K230204,K240035
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Device Description

The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following syndesmotic trauma using a TACTIX Vector Suture Loop and Buttons.
The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial skin nick, a larger medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the TACTIX Vector Syndesmosis System. It clearly states:

"No clinical data was required in support of the subject device."

Therefore, the information requested for a clinical study proving the device meets acceptance criteria is not applicable in this case. The FDA's substantial equivalence determination for this device was based on non-clinical tests and analyses.

Here's a breakdown of the requested information based on the provided document, clarifying that clinical study details are absent:

  1. A table of acceptance criteria and the reported device performance:

    • Acceptance Criteria (as implied by the non-clinical tests):
      • Steam sterilization validation successful.
      • Mechanical performance equivalent to predicate device.
      • Biocompatibility (based on biological evaluation) acceptable.
    • Reported Device Performance: "All results met the acceptance criteria."
    • Note: Specific quantitative performance metrics are not provided in this document, only that the criteria were met.

  2. Sample sizes used for the test set and the data provenance:

    • Not applicable as this was a non-clinical evaluation (e.g., sterilization validation, mechanical testing, biological evaluation). The "test set" would refer to the physical devices/materials tested in these non-clinical studies. Data provenance would be from the studies themselves (e.g., in-house testing, or third-party lab testing). No details on the number of samples for these non-clinical tests are provided.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable for non-clinical testing. Ground truth for these tests is established by standardized testing protocols and analytical methods.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable for non-clinical testing.

  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No MRMC study was done. This device is not an AI/software device that would involve human readers.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a medical device (surgical system) and not an algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • For the non-clinical tests, the "ground truth" is defined by the established scientific and engineering principles for sterilization, mechanical properties, and biocompatibility.

  8. The sample size for the training set:

    • Not applicable. No training set was used as this was not an AI/machine learning device.

  9. How the ground truth for the training set was established:

    • Not applicable. No training set was used.

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